FDA Approves Tremfya (guselkumab) One-Press Patient-Controlled Injector for Adults with Moderate-to-Severe Plaque Psoriasis
HORSHAM, PENNSYLVANIA, February 27, 2019 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved Tremfya One-Press, a single-dose, patient-controlled injector for adults with moderate-to-severe plaque psoriasis. Tremfya (guselkumab) is the first FDA-approved medication of its kind to offer the One-Press patient-controlled injector. One-Press was designed with patients in mind: it fits comfortably in the hand and offers a controlled injection that hides the needle throughout the process. Tremfya is administered as a 100 mg subcutaneous injection once every 8 weeks, after starter doses at weeks 0 and 4. Tremfya is intended for use under the guidance and supervision of a physician, and patients may self-inject with Tremfya One-Press after physician approval and proper training. Tremfya One-Press is now available in the U.S.
At times, patients living with plaque psoriasis may struggle with self-administering treatments due to a number of factors, including needle phobia. In the Phase 3, multicenter and randomized ORION study, patient experience with One-Press was assessed through a validated Self-Injection Assessment Questionnaire (SIAQ), which evaluated patient experience at weeks 0, 4 and 12 on a scale of 0 (worst) to 10 (best) across six domains (feelings about injections, self-image, self-confidence, pain and skin reactions during or after the injection, ease of use of the self-injection device and satisfaction with self-injection). The mean score for “Satisfaction with Self Injection” was 9.18 (with 10 indicating “Very Satisfied”) and the mean score for “Ease of Use” was 9.24 (with 10 indicating “Very Easy”).
The efficacy and safety of Tremfya administered with One-Press in patients with moderate-to-severe plaque psoriasis was also evaluated in the double-blind, placebo-controlled ORION study. In the study, a greater proportion of patients in the Tremfya group achieved an IGA score of 0 or 1 or a PASI 90 response at week 16 (81 percent and 76 percent, respectively) than in the placebo group (0 percent for both endpoints). The proportion of patients who achieved an IGA score of 0 at week 16 was higher in the Tremfya group compared to the placebo group (56 percent vs. 0 percent). The proportion of patients who achieved a PASI 100 response at week 16 was higher in the Tremfya group compared to the placebo group (50 percent vs. 0 percent). The majority of injection-site reaction symptoms with One-Press were mild and transient in nature.1
"The results of the ORION study showed the administration of Tremfya with One-Press was safe and effective, providing patients with a new, more convenient way to inject their treatment,” said Laura Ferris, M.D., Ph.D., Associate Professor, Department of Dermatology, University of Pittsburgh Medical Center*. “These findings are also exciting as they demonstrated that treatment with Tremfya helped half the patients achieve complete clearance with a PASI 100 response at week 16.”
The design of One-Press allows patients to control the rate and pressure of their injection. A soft click indicates when administration is complete resulting in nearly 99 percent of patients reporting a successful first injection;1 One-Press also includes a safety system that protects the needle after use. After three injections, patients still reported favorable outcomes with the usability of the One-Press device.1
“Patients living with plaque psoriasis often struggle with a conventional syringe when administering treatment,” said Newman Yeilding, M.D., Head of Immunology Development, Janssen Research & Development, LLC. “With the approval of One-Press, patients now have the option to self-administer Tremfya with a novel device that is both simple and intuitive to use.”
ORION is a Phase 3 study that evaluated the pharmacokinetics, efficacy and safety of Tremfya (guselkumab) administered with the One-Press injector. In this study, 78 patients were randomized to receive either Tremfya (100 mg at weeks 0 and 4 and every 8 weeks thereafter) [n=62], or placebo [n=16]. Baseline characteristics for patients were comparable to those observed in VOYAGE 1 and VOYAGE 2. The co-primary endpoints were the proportion of patients who achieved an IGA score of 0/1 and the proportion of patients who achieved a PASI 90 response at Week 16, the same as VOYAGE 1 and VOYAGE 2. Secondary endpoints included the proportion of patients who achieved an IGA score of 0 at week 16 and the proportion of patients who achieved a PASI 100 response at week 16.
Psoriasis is a chronic, autoimmune inflammatory disorder that results in the overproduction of skin cells, characterized by raised, inflamed, red lesions, or plaques, which can cause physical pain and itching.2 It is estimated that more than 7.5 million Americans live with the disease.3 Approximately 80 percent of those affected with psoriasis have mild to moderate disease, while 20 percent have moderate-to-severe plaque psoriasis.2
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.
Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenGlobal. Janssen Research & Development, LLC is one of the Janssen Pharmaceutical Companies of Johnson & Johnson.
*Dr. Ferris is a paid consultant for Janssen. She was not compensated for any media work.
Source: Janssen Pharmaceutical
Posted: February 2019
- Janssen Announces FDA Approval of Tremfya (guselkumab) for the Treatment of Moderate to Severe Plaque Psoriasis – July 13, 2017
- Janssen Submits Application to FDA Seeking Approval of Anti-Interleukin-23 Monoclonal Antibody Guselkumab for the Treatment of Moderate to Severe Plaque Psoriasis – November 17, 2016
Tremfya (guselkumab) FDA Approval History
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